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Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor

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ClinicalTrials.gov Identifier: NCT03662815
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Hangzhou Neoantigen Therapeutics Co., Ltd.
Information provided by (Responsible Party):
Yong Fang, Sir Run Run Shaw Hospital

Brief Summary:

This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients.

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.


Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Tumor Biological: iNeo-Vac-P01 Other: GM-CSF Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: iNeo-Vac-P01

Personal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF;

Peptides: 4 x 100 mcg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses;

GM-CSF: 4 x 40 mcg (total dose 160 mcg) given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses

Biological: iNeo-Vac-P01
Neoantigen peptides

Other: GM-CSF
immune adjuvant
Other Name: granulocyte-macrophage colony stimulating factor




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years ]
  2. Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 2 years ]
  2. Progression Free Survival [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Measurement of CD4/CD8 T lymphocyte subsets [ Time Frame: 2 years ]
  2. The polypeptide antigen - induced IFN-γ T cells responses [ Time Frame: 2 years ]
  3. Peripheral blood T cell receptor sequencing analysis [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must freely sign informed consent;
  • Aged 18 to 75 years old;
  • The expected survival period is more than 6 months;
  • ECOG score is 0 or 1;
  • Patients with advanced tumors who fail to receive standard therapy, and those who are not suitable or refuse standard adjuvant therapy;
  • Advanced malignant cancer diagnosed by pathology and imageology;
  • At least one measurable lesions;
  • To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;
  • The main organs function is normal, such as the heart, liver and kidney;
  • Haematological index:

neutrophil count≥1.5×109/L

hemoglobin≥10g/dL

platelet count≥100×109/L

  • Biochemical index:

Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN)

AST and ALT is less than or equal to 2.5 times the upper limit of normal value

Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value

  • Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
  • Good compliance, able to follow research protocols and follow-up procedures.

Exclusion Criteria:

  • Diagnosed as other malignant tumor, but cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia etc is excluded;
  • No neoantigen was found in the sequencing data;
  • There have been bone marrow or stem cell transplants;
  • Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to individualized tumor targeted polypeptides treatment;
  • Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
  • Active bacterial or fungal infections identified clinically (>= level 2 of NCI-CTC edition 3);
  • Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
  • People infected with herpes virus (scabbed for more than 4 weeks is excluded);
  • People infected with respiratory virus (cured for more than 4 weeks is excluded);
  • Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
  • Drug abuse, Clinical, psychological or social factor result in affecting informed consent or research implementation;
  • Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662815


Contacts
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Contact: Yong Fang 0571-87887825 307480770@qq.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Yong Fang, MD         
Sub-Investigator: Yong Fang, MD         
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Hangzhou Neoantigen Therapeutics Co., Ltd.

Publications:
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Responsible Party: Yong Fang, Clinical Professor, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT03662815     History of Changes
Other Study ID Numbers: INEO-P-002
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yong Fang, Sir Run Run Shaw Hospital:
Neoantigen
iNeo-Vac-P01
Peptide Vaccine

Additional relevant MeSH terms:
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Neoplasms
Vaccines
Sargramostim
Immunologic Factors
Physiological Effects of Drugs